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Inizio Engage is building a nationwide team of field based Pharmaceutical Sales Representatives. This is an excellent entry-level role in the healthcare and pharmaceutical industries. The team will be dedicated to providing services to Inizio’s client, Pfizer. The main objective of the Field Pharmaceutical Sales Representatives position is to increase awareness of high/at-risk patient type for COVID-19. This is a Field Contracted Team with the ability to create awareness on high/at-risk patients for COVID-19 with targeted HCPs along with urgent cares and retail pharmacies as directed. This role will report to the Area Business Manager. Your role will involve: * Provide P1 support to physicians about COVID-19 risk factors, disease progression, and treatment options * Educating identified targets to ensure customer preparedness on patient identification as above. * Build working relationships with customers through regular calls and ongoing contact with customers as defined in the Field Pharmaceutical Sales Contracted Team Statement of Work (SOW). * Ensure close collaboration with customer-facing colleagues to ensure goals are aligned and efforts are coordinated by channel and across field deployments. * Understand the customer and market landscape within assigned geographies and assess the business to prioritize opportunities and develop/implement a plan of action designed to maximize sales impact at the local level. * Operate in a team environment that is based on a culture of high collaboration and that encourages ideas. What will you be doing? * HCP engagement will involve probing, answering questions (e.g., drug to drug interaction management, where to find supply, who is high-risk and eligible for treatment) * Maintain an expert understanding of the Product, patient education, consumer education, and factors influencing the market environment. Understand and use only approved promotional materials to support marketing message. * Maintain an in-depth and knowledge of related disease state and market dynamics, quality programs, health information technology, care trends or other account-specific considerations that allow engagement in meaningful dialogue and adding value when calling on customers. * Implement the strategic call plan to exceed goals for assigned geographies. * Exhibit territory knowledge through customer analysis, including analyzing previous customer interactions and available data to maximize effectiveness of each call, and based on that information, tailoring a unique sales approach for each Target office. * Collaborate with a range of colleagues to prioritize opportunities at a local level, across channels, and develop/implement the strategy for targeted accounts. * Guide the retail pharmacy customer interface at the local level to further sales efforts. * Employ interaction techniques, including pre-call planning, opening, presentation focus and productive questions, issue identification and call summary. * Customize the delivery of sales messages to align with known customer needs. * Share information on approved support resources. * Complete all call reporting and inventory recording responsibilities following current procedures (based on scope of SOW). * Balance needed study and certification time, during off-territory hours, required to learn medical, product and policy information, and to maintain supplies, equipment, and records. * Prepare for and participate in all required sales conferences and training classes at local or remote locations. * Complete all required Compliance training within timelines set by client What do you need for this position? * Bachelor’s Degree * Minimum 2 years of relevant experience such as: * Pharmaceutical Sales Experience * Medical/Medical Device Sales Experience * Professional Sales or Promotional Activity * Small Business Owner or other Entrepreneurial experience, Marketing, Customer Service or Account Management * Relevant Healthcare/Scientific roles (e.g., RN, Pharmacist, PT, OT) * Educator (e.g., Teacher, Principal) * Full Time Military experience * Must live within 25 miles of the border of the territory * Urgent Care setting experience * Willingness to travel * Valid US driver’s license and a driving record in compliance with company standards Our Benefits: • Competitive compensation, • Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotions, • Employee discounts & exclusive promotions, • Recognition programs, contests, and company-wide awards, • Exceptional, collaborative culture, • Best Places to Work in BioPharma (2022, 2023, & 2024), • Certified Great Place to Work (2022, 2023, 2025) About Inizio Engage Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. To learn more about Inizio Engage, visit us at: ___ We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them. Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider for employment qualified applicants with arrest and conviction records. Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however, only qualified candidates will be considered.

Aquestive Therapeutics is hiring directly for several key positions, with Inizio Engage supporting the recruiting process. About Aquestive Therapeutics With more than 20 years of pioneering patient-centered innovation, we've transformed how millions access life-saving medications. Our track record speaks for itself: 6 FDA approvals, 2.5 billion doses delivered worldwide, and a presence across 6 continents. As we prepare to launch Anaphylm™, our latest breakthrough in overcoming patient barriers, we're building a sales team that shares our commitment to innovation that matters. The Role As a Therapeutic Specialty Representative (TSR), you’ll be on the front lines of a critical product launch, introducing Anaphylm to healthcare providers. Anaphylm has the potential to be the first and only FDA-approved, non-invasive, orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis. If approved, people at risk for severe allergic reactions would have a device-free, needle-free epinephrine option. Similar in size to a postage stamp, Anaphylm is administered as a thin, dissolvable film placed under the tongue. As a Therapeutic Specialty Representative (TSR), you will educate healthcare providers on how Anaphylm is designed to address barriers that prevent patients from carrying and administering epinephrine, building trusted relationships to drive adoption of Anaphylm. This role is ideal for ambitious sales professionals who thrive in a launch environment and who want their work to have genuine clinical impact. Key Responsibilities Strategic Territory Development * Design and execute territory business plans that identify high-potential accounts and drive measurable market penetration * Analyze prescribing patterns, payer landscapes, and competitive dynamics to prioritize efforts and maximize ROI * Partner with Regional Sales Managers to align field execution with broader commercial strategy Clinical Education and Relationship Building * Deliver compelling, compliant clinical presentations that demonstrate Anaphylm's value in addressing unmet patient need * Build trust-based relationships with key prescribers, practice administrators, and healthcare stakeholders through consistent engagement and authentic dialogue * Navigate complex clinical objections with insight and empathy, positioning Anaphylm as the solution to real-world challenges Access and Pull-Through Excellence * Master payer coverage dynamics across your territory—national, regional, and local insurance landscapes * Collaborate with Market Access, to overcome prior authorization barriers and ensure seamless patient onboarding * Drive formulary wins and in-office pull-through by equipping providers with the tools and knowledge they need Flawless Execution * Orchestrate high-impact customer engagement programs including lunch-and-learns and speaker events * Maintain CRM excellence: capture detailed call notes, payer feedback, sampling activity, and strategic next steps with precision * Ensure 100% compliance with PDMA sampling requirements, AE/product complaint reporting, and promotional guidelines Field Intelligence * Serve as the eyes and ears of the organization, sharing customer insights, competitive intelligence, and best practices that inform strategy * Contribute to a culture of continuous learning and improvement across the sales organization Qualifications Required * Bachelor's degree * 3+ years of pharmaceutical, specialty, or B2B sales success with proven track record of exceeding targets * Deep understanding of payer coverage, prior authorization workflows, and access barrier navigation * Strong analytical skills with demonstrated ability to translate data into actionable territory strategies * Willingness to travel overnight 50% for customer meetings, conferences, and sales meetings Preferred * Launch experience in specialty or allergy markets. * Specialty pharmacy or hub services background * Experience selling products that address medication adherence or administration barriers Who Thrives Here * Mission-driven achievers motivated by outcomes results-oriented with passion for improving patient outcomes * Strategic hunters who combine creativity, persistence, and disciplined execution to drive market growth * Resilient and adaptable performers able to navigate obstacles, adapt quickly, and thrive in a competitive, fast-paced launch environment * Collaborative team players who elevate others while maintaining accountability for outcomes * Consultative and influential communicators who earn trust, educate customers, and drive conversion through insight and conveying value Compliance * Ensure field compliance with all company and industry standards, including: * Sampling and PDMA (if applicable) * Adverse Event (AE) and product complaint reporting * On-label and compliant promotional dialogue * CRM data quality and timely documentation * Maintain alignment with corporate policies, training, and legal/regulatory requirements. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected salary range: $125,000 - $150,000/per year. Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended as an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Retail pharmacists: Ready to escape the chaos? This is your chance. A rapidly growing LTC pharmacy in SW Florida is hiring a Staff Pharmacist — offering a closed-door environment with no retail madness and meaningful patient impact. What You’ll Do • Verify, prepare, and dispense LTC medications, • Support techs + collaborate with clinical teams, • Ensure accuracy, safety, and compliance, • Help improve workflows and patient outcomes, • LTC experience not required., • 8–10 hour shifts + rotating weekends Requirements: • PharmD or BS Pharmacy, • Active Florida license, • Detail-oriented, team-focused mindset What You Get • Competitive pay & strong benefits, • 401(k) with match, • PTO + holidays, • Supportive, mission-driven culture, • A real alternative to retail burnout Ready for better work-life balance? Apply now or message Jana @ ridgemontresources.com for immediate consideration!

Job Description • Required Qualifications:, • Education:, • High School Diploma or GED required., • Associate’s degree or coursework in business, supply chain, or pharmacy technology preferred., • Experience:, • Minimum of 2 years of hospital pharmacy experience required., • Prior experience as a pharmacy buyer or inventory specialist in an acute care setting strongly preferred., • Experience with pharmacy information systems (e.g., Pyxis, Omnicell, EPIC, and Meditech) and purchasing software (e.g., Cardinal, McKesson, and Cencora) preferred., • Licensure/Certification:, • Florida Pharmacy Technician Licensure required based on hospital policy., • Certified Pharmacy Technician (CPhT) preferred., • Essential Job Functions:, • Purchase pharmaceuticals, biologicals, and supplies from approved vendors in accordance with hospital purchasing policies and group purchasing organization (GPO) contracts., • Maintain appropriate stock levels to meet patient care needs while minimizing waste and expiration., • Monitor inventory levels and perform routine cycle counts and reconciliations., • Ensure timely receipt, verification, and storage of all medications according to manufacturer and regulatory standards., • Process returns, recalls, and credits in collaboration with vendors and wholesalers., • Evaluate purchasing trends to identify cost-saving opportunities and formulary standardization., • Track and report on purchasing budgets, cost variances, and savings initiatives., • Ensure compliance with all DEA, FDA, Board of Pharmacy, and Joint Commission standards related to medication purchasing and storage., • Maintain appropriate documentation for controlled substances ordering and receipt., • Serve as the primary contact for wholesalers, manufacturers, and distributors., • Resolve issues related to backorders, shortages, and product substitutions., • Work with pharmacy leadership to optimize vendor contracts and purchasing programs., • Assist with implementation of new drug products and discontinuations in collaboration with the Pharmacy and Therapeutics (P&T) Committee., • Participate in audits, inspections, and process improvement initiatives., • Train and assist pharmacy staff in inventory procedures and purchasing system use., • Knowledge/Skills/Abilities:, • Strong understanding of drug purchasing, inventory management, and GPO processes., • Excellent organizational, analytical, and communication skills., • Ability to work independently, prioritize, and manage multiple tasks., • Proficient in Microsoft Excel, Word, and inventory management systems., • Demonstrated commitment to accuracy, compliance, and cost-effective operations., • Working Conditions/Schedule:, • Typical hospital environment with exposure to medications and supplies., • May require occasional lifting (up to 30 lbs.) and standing for extended periods., • Monday–Friday schedule; occasional weekends or holidays as departmental needs require.

Job Description Location: On-Site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami FL locations About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) * HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. * HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. * HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) * HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Manager, Clinical QA will collaborate closely with Regulatory Affairs, QA, R&D and other cross functional teams within the Company to provide GCP/GLP/GPV and compliance-related advice to internal clinical study teams. This will be accomplished through ensuring tactical support is provided to assignments and wherever necessary, taking the lead in ensuring project related procedural documents, comply to relevant GxP’s and regulatory requirements and guidelines. Role and Responsibilities: * Partnering and collaborating with key stakeholders (R&D teams) to ensure that appropriate Quality support is provided to Summit Clinical and pre-clinical programs * Ensuring end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP) * Liaising with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actions * Supporting CRO-relevant meetings, when necessary, to provide quality overview/ training to relevant stakeholders * Providing support during the development and execution of Corrective and Preventive Actions (CAPAs). Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined, implemented, and closed. * Support formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due course * Identifying areas of continuous process improvement and engaging QA and key stakeholders as necessary * QA support in interactions with internal and external contacts and Health Authorities (HA), as appropriate. In collaboration with the Global QA team, ensure inspection management by assisting in preparing program teams for FDA, EU, and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections. * Support in providing interpretation of regulations and company process standards, guidelines, policies, and procedures to personnel for assigned programs or for continuous improvement projects * Supporting or leading development and driving the implementation of study/program-specific quality plans to ensure proactive management of quality * Supporting rectifying any necessary vendor-relevant issues identified for the assigned program * Ensuring that protocols for assigned programs can be operationalized and address potential risks with key stakeholders * Perform internal audits as applicable * All other duties as assigned Experience, Education and Specialized Knowledge and Skills: * Bachelor's Degree in Life Sciences, Pharmacy, or Nursing required * Master's Degree or other advanced degree preferred * Minimum of 5+ or more years Quality Assurance experience and or Clinical Operations involvement in regulated activities or equivalent experience required * Broad understanding of global expectations of Health Authorities in the management of clinical trials preferred * Thorough understanding of international GCP/GLP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice preferred • Ability to travel up to 20% Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable * Strong computer and database skills * Attention to detail, accuracy and confidentiality * Clear and concise oral and written communication skills * Excellent organizational skills * Critical thinking, problem solving, ability to work independently * Must be able to effectively multi-task and manage time-sensitive and highly confidential documents * Communicate effectively and articulate complex ideas in an easily understandable way * Prioritize conflicting demands * Work in a fast-paced, demanding and collaborative environment The pay range for this role is $139,000-$163,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description Specific job functions include: · Review and understand PBM contracts for all relevant pricing terms · Review and understand plan design documents provided by PBM or client · Utilize company’s proprietary Compliance Model · Calculate client contractual financial guarantees, admin fees, rebates and other terms as required by client contract · Assemble audit reports and summarize findings · Document all potential issues and track decisions · Collaborate with account management and pharmacy consultants to discuss results with clients and vendors · Provide documentation during follow-up negotiations and discussions · Work with IT to further develop Compliance Model logic and capabilities · Assist in other financial projects as needed Requirements: · Bachelor’s degree in Business, Finance, or other health related field · At least 3 years of either a) pharmacy benefit audit or b) claim adjudication research experience on one or more PBM platforms · Working knowledge of the PBM industry and pharmacy benefit claims Desired Skills: · Proficient in Microsoft Office, with extensive experience working with Excel · Basic SQL query building · Strong verbal and written communication skills · Detail-oriented · Solid, independent worker (this position will likely be based in the applicant’s home) · Pharmacy Technician Certification (preferred) Company DescriptionLeading specialty benefits management company in Puerto Rico and South Florida. Our innovative care management model integrates the needs of providers, payors and members to ensure the delivery of high quality, cost effective care while realizing substantial millions of dollars savings that keep the cost of healthcare down. We are building a model for managing care delivery that embodies traditional values, promises reliability, and embraces flexibility and technology. Through our experience in the healthcare industry, the company aims to improve healthcare outcomes, achieve cost savings and serve as a single point of contact to move into value-based care.Leading specialty benefits management company in Puerto Rico and South Florida. Our innovative care management model integrates the needs of providers, payors and members to ensure the delivery of high quality, cost effective care while realizing substantial millions of dollars savings that keep the cost of healthcare down.\r\n\r\nWe are building a model for managing care delivery that embodies traditional values, promises reliability, and embraces flexibility and technology. Through our experience in the healthcare industry, the company aims to improve healthcare outcomes, achieve cost savings and serve as a single point of contact to move into value-based care.

Job Description Location: Menlo Park, CA, Princeton NJ or Miami FL. onsite 4 days per week About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: • HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib)., • HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. Overview of Role: The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: • Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met, • Initiates and builds solid professional relationships with key opinion leaders and clinical site staff, • Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time, • Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data, • Proactive identification and management of study related risks, • Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements, • Responsible for reviewing and managing study related plans, processes including, • Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring, • Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met, • Reviews and approves essential document packages to enable timely site activations, • Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report, • Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates, • Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary, • Responsible for oversight on the maintenance of the TMF and completeness at the end of the study, • Perform periodic QC of the TMF, • Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs, • Ensures the study is “inspection ready” always, • Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project, • Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred, • Minimum of 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization, • Prior phase II and III experience required, • A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, • Experience with budget forecasting and management, • Experience with clinical studies in oncology, • Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%), • Proven proficiency in overseeing large complex studies being managed in house and by a CRO, • Demonstrated ability to lead teams and work in a fast-paced team environment, • Experienced and enjoys building relationships with KOLs and site personnel, • Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues, • Demonstrated ability to build and deliver on patient enrollment strategies, • Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives, • Demonstrated ability to comprehend complex scientific concepts and data, • Proficient in reviewing and assessing clinical data, • Possesses excellent planning, time management & coordination skills, • Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs, • Experience in working in a small organization Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description JOB TITLE: Clinical Research Coordinator REPORTS TO: Research Executive Director FLSA STATUS: Exempt GENERAL DUTIES • Perform work independently under the general guidance of a supervisor., • Create and/or maintain all documents and records related to the study., • Ongoing visits and correspondence with study participants to monitor the condition of patients and collect study data., • Careful documentation of participant data per study guidelines. Maintains study records in a timely and detail-oriented fashion., • Create study specific documents (telephone screen questionnaire, source documents, site-level and master-level general logs, intake forms, etc.)., • Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol., • Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability. -In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings., • Responsible for accurate and timely data collection, documentation, entry, and reporting., • Participates in required training and education programs. Participates in education and awareness of clinical research/active studies to clinical staff., • Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality., • Communicates with the physician regarding study requirements, need for dose modification, and adverse event reporting., • Ensuring that the necessary supplies and equipment for a study are in stock and in working order., • Manage the inventory of equipment, supplies, and laboratory kits and order more as needed., • Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur., • Knows the contents and maintenance of study-specific clinical research regulatory binders., • Receives supply and IP orders/shipments and confirms accuracy of delivery. This includes logging and storing the IP as per protocol and procedures., • Recruits and screens potential study participants and performs intake assessments., • Collects and processes laboratory specimens per protocol., • Sound knowledge of collection procedures for central and local laboratories., • Inputs data and patient information into electronic systems., • Administer questionnaires., • Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants., • Identifies, reports, and helps problem-solve protocol deviations and unanticipated occurrences., • Engage with study monitors and prepare for interim monitoring visits., • 2+ years of previous experience working in a research setting., • Excellent written and verbal communication skills., • Superior organizational and time management skills., • Capable of working independently with minimal supervision and also as part of a team., • Skilled with standard computer programs, including the MS Office suite., • Understanding of medical terminology as well as standard clinical procedures and protocols., • Attention to detail and the ability to accurately collect and record data., • Knowledge of good clinical practice (GCP) guidelines and regulations governing clinical research., • Proficiency in relevant computer software and electronic data capture systems., • Compensation depends on experience., • See benefits package for full list of benefits. Hours of work: Full-time position Monday - Friday; hours may vary based on the current needs of the company. Schedule will be based on a 40-hour work week. Overtime expectations: This position is not expected to have overtime. If overtime is expected, management will communicate with the Study Coordinator to adjust schedules with at least 2 weeks' notice. Work environment: Ability to lift up to 20 pounds for a short period and capable of standing for extended periods of time. Travel requirements: This position requires travel to the additional RASF/Gastromed locations if needed. Reporting To • 90-day probationary period upon commencement of employment, • Yearly evaluation with Vice President and Executive Director Employee Health Ins is covered at 100%. We also offer Dental, Vision, Life and 401K Benefits.

Job Description Contract Attorney or Paralegal - 340B Program (Remote) Remote (Any State License Accepted) Employment Type: Contract (Set your own hours for a project) About the Role: We are seeking a highly skilled and detail-oriented Contract Attorney or Paralegal with expertise in the 340B Drug Pricing Program to join our team on a remote, contract basis. This role will provide critical legal and regulatory support to ensure compliance with 340B program requirements, assist with audits, and help navigate complex legal issues related to pharmaceutical pricing and healthcare regulations. The ideal candidate will have a strong background in healthcare law, contract review, and regulatory compliance, with specific experience in the 340B program. Key Responsibilities: • Provide legal analysis and guidance on 340B program compliance, including eligibility, contract pharmacy arrangements, and regulatory changes., • Review, draft, and negotiate contracts related to the 340B program, including agreements with covered entities, contract pharmacies, and third-party administrators., • Assist with internal and external audits, including preparing documentation, responding to inquiries, and ensuring compliance with 340B program requirements., • Monitor and interpret federal and state regulations, guidance, and policies related to the 340B program and healthcare compliance., • Collaborate with internal stakeholders, including legal, compliance, and pharmacy operations teams, to address legal and regulatory risks., • Conduct legal research and prepare memoranda on issues related to the 340B program, healthcare law, and pharmaceutical pricing., • Support dispute resolution efforts, including responding to HRSA (Health Resources and Services Administration) inquiries or allegations of non-compliance., • Stay up-to-date on industry trends, litigation, and enforcement actions related to the 340B program. Qualifications: • For Attorneys: Juris Doctor (JD) degree from an accredited law school and active bar membership in good standing in any U.S. state., • For Paralegals: Paralegal certification or equivalent experience, with a strong background in healthcare law or regulatory compliance., • Minimum of 3-5 years of experience working with the 340B Drug Pricing Program, healthcare compliance, or pharmaceutical law., • In-depth knowledge of 340B program regulations, HRSA guidelines, and related federal and state laws., • Experience drafting, reviewing, and negotiating contracts, particularly in the healthcare or pharmaceutical industries., • Strong analytical skills with the ability to interpret complex regulations and provide actionable recommendations., • Excellent written and verbal communication skills, with the ability to communicate legal concepts to non-legal stakeholders., • Self-motivated and able to work independently in a remote environment., • Proficiency with Microsoft Office Suite and legal research tools (e.g., Westlaw, LexisNexis). Preferred Qualifications: • Experience working with covered entities (e.g., hospitals, clinics, federally qualified health centers) or contract pharmacies., • Familiarity with Medicaid drug rebate programs and other pharmaceutical pricing regulations., • Prior experience supporting 340B program audits or dispute resolution processes. Why Join Us? • Fully remote position with flexible hours., • Opportunity to work on impactful projects within the healthcare and pharmaceutical industries., • Collaborative and supportive team environment.

Job Description << PHARMACY TECHNICIAN/MEDICAL PROCESSOR NEEDED FOR MEDICAL PRACTICE >> We are searching for TOP TALENT! NuLife Institute is Miami’s premier medical facility for Functional, Integrative Medicine and Age Management. It is the only facility of its kind to provide personalized non-surgical age reversing treatment plans custom-tailored to your body, using your very own Internal Blueprint™. We are searching for a driven and customer service oriented Medical Processor/Pharmacy Technician to process medication treatment programs to help drive our patient retention and practice operations success. This person plays a critical role in ensuring that patients receive the correct medications safely and efficiently, making their skills and attention to detail indispensable to any team. This role will may become a hybrid role in the future with working from locations and home once candidate is able to work autonomous. Daily Responsibilities and Required Skills Daily Responsibilities: • Reviewing incoming Patient Program Orders:, • Reviewing and crossing checking doctor’s orders line up with medication to be sold and dispensed., • Reviewing and taking payment., • Medication Preparation and Dispensing:, • Accurately measure, count, and label medications as prescribed in compliance with state and federal regulations., • Prescription Processing:, • Receive and verify prescriptions from patients within patient programs and/or our healthcare provider notes., • Input prescription information into the pharmacy system., • Pharmacy Interaction:, • Review Invoices, • Direct connection with pharmacies for orders, pricing and ongoing issues., • Inventory Management:, • Maintain stock levels and organize inventory., • Check for expired medications and dispose of them appropriately., • Compliance and Record-Keeping:, • Ensure all prescriptions meet regulatory standards., • Ensure compliance with State and Federal regulations and company policies and procedures that ensure the safety, security and privacy of the staff and its customers., • Individual provides support and guidance to staff in processing medical programs efficiently and effectively. Requirements Required Skills: • Math Skills:, • Proficiency in basic arithmetic for measuring, weighing, and calculating dosages., • Ability to interpret and calculate proportions for compounding medications., • Attention to Detail:, • Double-checking prescriptions to prevent errors., • Ensuring labels, dosages, and patient information are accurate., • Organization:, • Keeping the workspace tidy and medications properly sorted., • Managing multiple tasks efficiently in a fast-paced environment., • Communication:, • Effectively interacting with staff and healthcare providers., • Promoting excellent customer service to ensure patient satisfaction from team members, including troubleshooting challenges, and if necessary, developing processes to circumvent possible recurrences., • Explaining instructions clearly and professionally., • Technical Proficiency:, • Ability to adapt to new online systems., • Problem-Solving:, • Resolving issues or prescription discrepancies quickly., • Addressing customer inquiries and concerns empathetically., • Compliance Awareness:, • Understanding of federal and state regulations regarding controlled substances and prescription medications., • Adherence to HIPAA and patient privacy laws. QUALIFICATIONS/REQUIREMENTS • General Computer knowledge and Experience (Word, Excel), • Prior Experience with Electronic Medical Records (EMR) or CRM System (ie. Salesforce), • Strong organizational skills are imperative, • Ability to be self-directed and a self-starter, • Highly strategic, creative and process oriented thinker, • Proven ability to resolve conflicts and discrepancies, • Excellent customer service and communication skills., • Experience working with prescriptions, healthcare, or customer-facing roles (preferred), • Proficient in understanding and mastering workflow and system processes, • Knowledge of HIPAA OSHA, and other federal, state, and local regulations, • Knowledge of maintaining medical supply inventory for medical office, • Ability to communicate professionally with Medical Team, Administrative Team, distributors/supplies, Pharmacy Representatives, patients and guests Benefits Retirement Plan • Medical, • Dental

Job Description WE ARE HEALTHCARE SYSTEMS OF AMERICA. Our mission is to elevate healthcare standards, improve patient outcomes, and create value for communities across the United States. Healthcare Systems of America (HSA) is more than a healthcare provider-we're a community built on excellence, innovation, and compassion. If you're looking for a career that makes a difference, empowers you to grow, and gives you the opportunity to impact lives, HSA is where you belong. Healthcare Systems of America operates 8 community hospitals across 3 states. We service a multitude of patients and their families across our vast network, while remaining committed to the professional development of our staff, the functional improvement of our patients, and the cultivation of strong partnerships within our communities. WHAT WE OFFER • Career Growth & Development - We are an essential, stable and growing company with many opportunities for training and advancement within the medical field that all employees and team members can benefit from., • Supportive & Inclusive Culture - We foster an environment where every team member is valued, heard, and empowered to succeed. This IT Project Manager, Clinical applications plays a pivotal role in ensuring the seamless integration of newly acquired healthcare facilities into the HSA Corporate health system's technology infrastructure. This individual oversees end-to-end IT project execution related to M&A activities, including due diligence, systems assessment, infrastructure alignment, and EMR/EHR onboarding. Working closely with leadership from IT, Clinical operations, compliance, and vendor partners, the Project Manager ensures timely, secure, and cost-effective technology transitions that align with organizational goals and regulatory requirements. The successful candidate will collaborate closely with the Clinical and Ancillary IT Applications teams to support system implementation initiatives across key operational workflows. Focus areas will include, but are not limited to: • Nursing, • Surgical Services and Anesthesia, • Lab/Blood Bank/Pathology, • Pharmacy and Pyxis, • Emergency Department, • Order Entry, • Physician Documentation PRIMARY RESPONSIBILITIES • Lead and manage the full lifecycle of Clinical-related projects, including new system implementations, upgrades, migrations, and optimization efforts., • Collaborate with stakeholders to define project scope, objectives, timelines, and deliverables that support clinical workflow and business needs., • Drive integration efforts between MEDITECH applications and third party systems and modalities, ensuring interoperability, data accuracy, and efficient user workflows., • Coordinate with clinical and ancillary departments, vendors, and IT teams to ensure alignment of system capabilities with end-user requirements., • Develop and maintain detailed project plans, including schedules, milestones, resource allocation, risks, and mitigation strategies., • Track project performance, identify variances, and implement corrective actions as needed to ensure timely and on-budget delivery., • Manage change control, testing coordination, go-live planning, and post-implementation support activities., • Serve as a liaison between clinical leadership, technical teams, and executive sponsors, facilitating clear communication and issue resolution., • Document project status, technical configurations, workflow impacts, and system enhancements., • Support end-user training and knowledge transfer activities to promote system adoption and operational readiness., • Provide project management support for additional IT or clinical projects as needed, based on organizational priorities and PMO resource planning., • Work within a matrixed environment and large-scale implementation Program structure to iteratively deliver projects to meet the overarching goals of the organization and Corporate IT department. EXPERIENCE/EDUCATION REQUIREMENTS • Bachelor's degree in Healthcare Administration, Information Systems, or related field (Master-s degree preferred)., • Minimum of 5 year of project management experience in a healthcare setting with a focus on clinical and/or ancillary systems., • Hands-on experience with MEDITECH EHR is required, particularly in integration or optimization roles., • Previous experience managing large-scale, cross-functional projects in clinical or ancillary environments. SKILLS/REQUIREMENTS • Proficient in healthcare IT standards including HL7, HIPAA, and security/privacy requirements., • Excellent project planning, coordination, and risk management skills., • Strong communication and stakeholder engagement abilities. Capable of working with Executives, IT staff, and vendors., • Ability to balance multiple priorities, navigate complex healthcare environments, and lead cross-functional teams., • Experience using project management tools (e.g. Microsoft Project, Smartsheet, Jira)., • PMP or similar project management certification preferred., • Ability to work independently, proactively resolve issues, and drive initiatives to completion.

Job DescriptionCompany Description Starting from $67,000 annually plus monthly training incentive of $1,500* *Pay is based on location, experience, and qualifications etc. *Monthly incentives after training vary and are based on restaurant profitability At Raising Cane’s Chicken Fingers®, we serve only the most craveable chicken finger meals – it’s our One Love! Known for our great Crew and cool Culture, we follow a Work Hard. Have Fun. philosophy. Raising Cane’s is the fastest-growing chicken concept around and is on track to be a Top 10 Restaurant Brand in the United States. Each Crewmember is important to our rapid growth and enduring success. Now is your chance to join the Team and Raise The Bar! Benefits offered for all Full-time Restaurant Managers: • Medical, Dental, Vision & Pharmacy Benefits, • Dependent Care & Healthcare Flexible Spending Accounts, • Company-provided Life and Disability insurance, • Hospital Indemnity, Accident and Critical Illness, • 401(k) With Employer Match (age 21 & older), • Access to financial advisors for budget and retirement planning, • One Pass Gym Membership Program, • Tuition Reimbursement, • Crewmember Assistance Program, • Weekly Pay!*, • Competitive pay + monthly bonus, • Paid Time Off & Sick time, • 8 paid Holidays a year**, • Early closure for company events, • Casual Work Attire, • Perkspot Employee Discount Programs, • *Raising Cane's pays weekly, except in some states (e.g., California) where the company pays bi-weekly., • **Some locations may vary Job Description Your Role at Raising Cane’s: The Restaurant Leader is responsible for strategic direction for their restaurant and must maintain operations standards and drive results through people development, sales and profit growth. This role is tasked with teaching, modeling and upholding Raising Cane’s culture standards for all crewmembers, customers and partners. The physical work environment includes working in a fast-paced kitchen environment (which requires extended periods of physical exertion, such as walking, standing, lifting and bending) and interacting with customers. It also includes both inside and outside work in varied temperatures, working with and around food products, common allergens, industrial equipment, commercial cleaning products that require the use of personal protective equipment and physical activities necessary to complete the responsibilities of the job. Your Impact and Responsibilities: Purpose of the position: • Ensures overall financial success of the restaurant and is responsible for forecasting and budgeting, • Ensures overall restaurant compliance to company standards, policies and laws, • Hires and terminates management-level crewmembers including status change and payroll process, • Creates crewmember work and training schedules, • Develops management-level crewmembers including performance management, • Acts as manager on duty, opens and closes the restaurant, manages cash handling, • Enforces Raising Cane’s policies and standards, • Uses required tools, forms and logs to support shift execution, document results and take corrective action when needed, • Deploys crewmembers during a shift and provides exemplary customer service, • Utilizes reward and recognition program for the crewmembers in the restaurant, • Authorizes employee functions requiring manager approval (e.g. discounts, timeclock overrides, etc.), • Ensures cleanliness of the restaurant and ensures the facility is in good working order, • Achieves and maintains training restaurant status, • Achieves “meets expectations” or better metrics in all crewmember and operations performance metrics, • Completes other duties as assignedQualifications Requirements for Success: • Detail-oriented, organized and able to manage multiple priorities that may be constantly changing, • Self-driven, flexible, and highly energetic with strong analytical, written and verbal communication skills, • Able to work effectively and efficiently both independently and collaboratively, • Able to recognize problems, set goals, create plans and convert plans into action to solve problems, • Able to measure performance, subjectively and objectively with a high level of emotional intelligence, • Proficient in a variety of technology systems including Microsoft Office (Excel, Word and Outlook) and ability to learn and adapt to new systems quickly, • Able to work a variety of shifts including days, evenings and weekends and travel as needed for work-related functions and training, • Able to manage all public dealings in a professional manner, consistent with Raising Cane’s policies and acts as a brand ambassador inside and outside the restaurant, • 5+ years of restaurant or retail management experience, • New restaurant opening and local restaurant marketing experience preferred, • Must be 18 years of age or older, • High school diploma or equivalent required, some college preferred, • Possess a valid driver’s license Additional Information All your information will be kept confidential according to EEO guidelines. Terms of Use Privacy Policy Candidate Privacy Notice It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

University of Miami is seeking a Ophthalmic Technician Level I for a job in Miami, Florida. Job Description & Requirements • Specialty: Ophthalmic Technician, • Discipline: Allied Health Professional, • Duration: Ongoing, • 40 hours per week, • Shift: 8 hours, days University of Miami Job ID #R100089111A. About University of Miami The University of Miami is considered among the top tier institutions of higher education in the U.S. for its academic excellence, superior medical care, and cutting-edge research. At the U, we are committed to attracting a talented workforce to support our common mission of transforming lives through teaching, research, and service. Through our values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity and Teamwork (DIRECCT) we strive to create an environment where everyone contributes in making the University a great place to work. We are one of the largest private employers in Miami-Dade County; home to more than 16,000 faculty and staff from all over the world. Benefits • Holiday Pay, • 403b retirement plan, • Sick pay, • Wellness and fitness programs, • Employee assistance programs, • Medical benefits, • Dental benefits, • Vision benefits, • Benefits start day 1, • Continuing Education, • Sign-On bonus

University of Miami is seeking a Ophthalmic Technician Level II for a job in Miami, Florida. Job Description & Requirements • Specialty: Ophthalmic Technician, • Discipline: Allied Health Professional, • Duration: Ongoing, • 40 hours per week, • Shift: 8 hours, days University of Miami Job ID #R100087641A. About University of Miami The University of Miami is considered among the top tier institutions of higher education in the U.S. for its academic excellence, superior medical care, and cutting-edge research. At the U, we are committed to attracting a talented workforce to support our common mission of transforming lives through teaching, research, and service. Through our values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity and Teamwork (DIRECCT) we strive to create an environment where everyone contributes in making the University a great place to work. We are one of the largest private employers in Miami-Dade County; home to more than 16,000 faculty and staff from all over the world. Benefits • Holiday Pay, • 403b retirement plan, • Sick pay, • Wellness and fitness programs, • Employee assistance programs, • Medical benefits, • Dental benefits, • Vision benefits, • Benefits start day 1, • Continuing Education, • Sign-On bonus

Job Description Organizational Mission/Federal and State Regulations and Accreditation Standards 1. Services are available in accordance with organizational mission and core values., 2. Care and services provided by organization personnel and contracted organization personnel are coordinated and integrated and in accordance with local laws, regulations and accreditation standards. Responsible for the recruiting, retention and development of field staff. 1. The Recruitment and retention of employees for his/her respective site., 2. Responsible for arranging and implementing the onboarding/orientation and 90-day performance evaluations., 3. Responsible for coordination the completion of initial and all annual competencies of direct care staff., 4. Responsible for implementing and adhering to Moments way philosophy of care., 5. Responsible for timely annual performance evaluations for all direct care staff., 6. Responsible for ensuring the adherence of ongoing monthly educational requirements of all staff., 7. To ensure that exit interviews are conducted in accordance with organizational policies, for any member of the Clinical Team exiting the organization and that this information is submitted to the QA department for tracking and trending analysis. Budgeting/Productivity 1. Responsible to ensure that the daily/weekly/monthly productivity requirements for each direct care giver are met and monitors this report., 2. Monitors Key Performance Indicators on a periodic basis and resolves concerns in conjunction with other related departments., 3. In conjunction with Executive Management is responsible for the review of all pharmacy and DME related bills/expenses, investigating any variance and documenting the reasons., 4. Is responsible to review and approve all vendor bills in a timely manner. Provision of Quality Care 1. Is responsible for ensuring the on call schedule to meet the patient's needs and organizational policy., 2. Participates in rotating Administrator on Call., 3. Is responsible for the staff schedule to ensure the plan of care is met and that quality services are provided in accordance with each patient's plan of care., 4. Is responsible to document, investigate and report all alleged complaints in accordance with organizational policy, and communicate with the Compliance/QA department any adverse results., 5. Responsible to review and take the necessary corrective action of organizational identified quality measures for improvement of patient outcomes in conjunction with the QA department., 6. Responsible to review and take the necessary corrective actions of ongoing measurement of site-specific Performance Improvement Plan(s)., 7. Responsible to review and take the necessary corrective action of chart audits for patients with long LOS, 8. To ensure the timely reporting and review with staff the trending of all Adverse events., 9. Responsible to review and take the necessary corrective action to of IDG documentation, 10. Responsible to review and take the necessary actions to ensure the timeliness of documentation from the clinical team., 11. Responsible to review and take the necessary actions to ensure the timely review of CAHPS outcomes with clinical team with objectives for the team to demonstrate improvement is identified areas., 12. To ensure the timely investigative documentation of staff reported concerns/events.(ethical advocate) The Clinical Manager will participate as a member of the following: A. Management Team B. Advisory IDG Committee C. Quality Assessment Performance Improvement Committee The Clinical Manager will be qualified and possess appropriate clinical training and experience, as verified by: 1. Education, training, and previous work experience, 2. Current professional licensure, 3. Interview for understanding of care and service being provided as well as population being served, 4. Management experience and clinical knowledge Qualifications; 1. Nursing and hospice aide services will be under the supervision of a registered nurse who has at least two (2) years of hospice or community-based health care experience., 2. Preferred Hospice experience of a minimum of one ( 1 ) year., 3. Excellent communication skills, both verbal and written., 4. Knowledge of Hospice Industry best practices, 5. Capable to utilize standard email system, texting, other software systems in order to ensure comprehensiveness of job-related duties., 6. Current RN license in the state of the agency., 7. Current and valid Driver's license with a reliable source of transportation., 8. Clear criminal background check., 9. Willing to function as part of the team for improved patient outcomes. OSHA requirements; Moderate to heavy lifting up to 50 lbs. Mild to Moderate exposure for bloodborne pathogens Moderate exposure of communicable diseases Prolonged sitting in a car/desk Prolonged use of a telephone/computer/tablet Job Type: Full-time Experience: • nursing: 2 years (Preferred), • Health insurance, • Dental insurance, • Vision insurance, • Monday to Friday

Job Description Position Summary: We are seeking a highly experienced and motivated Manager, Regulatory Affairs, to join our growing Regulatory Affairs team in Miami. This role is critical to ensuring compliance with US regulatory requirements and supporting the development, approval, and lifecycle management of medical devices. The ideal candidate will possess deep expertise in U.S. FDA regulations, and have a good general understanding of EU MDR, and international standards, and will contribute to strategic regulatory planning and execution. Essential Duties and Responsibilities · Lead regulatory strategy and submissions for Class II and III medical devices in the U.S. · Prepare and manage regulatory submissions including 510(k), PMA Supplements, annual reports. · Serve as the US regulatory lead on cross-functional project teams, ensuring alignment with clinical, quality, and R&D functions. · Interpret and apply regulatory requirements to product development, labeling, and review of advertising and promotional materials. · Monitor changes in regulatory requirements and communicate impact to internal stakeholders. · Support audits and inspections by regulatory authorities. · Lead post-market regulatory assessments and submissions, including periodic reports, vigilance reporting, and regulatory renewals. · Manage complaint handling activities, ensuring timely investigation, documentation, and regulatory reporting in compliance with applicable standards. Qualifications: · Bachelor’s degree in engineering, life sciences, pharmacy, or related field. Advanced degree preferred. · Minimum 10 years of experience in regulatory affairs within the medical device industry. · Proven track record of successful submissions to FDA. · In-depth knowledge of FDA 21 CFR 820, ISO 13485, and other applicable standards. · Strong communication, leadership, and project management skills. · Experience with eQMS systems and electronic document control preferred.